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Sponsored by: |
Genentech |
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Information provided by: | Genentech |
ClinicalTrials.gov Identifier: | NCT00081614 |
The primary purpose of the study is to assess the potential benefit of combining two targeted therapies (an anti-EGF inhibitor along with an anti-VEGF inhibitor). The goal will be to determine whether the addition of Erlotinib to Avastin will improve the benefit in metastatic renal cell carcinoma (RCC) with regard to time to progression, response rate, duration of response, and survival compared with Avastin alone. Since Avastin has been shown to be active in renal cancer, the goal will be to assess whether this activity can be enhanced with Erlotinib.
Condition | Intervention | Phase |
---|---|---|
Renal Cell Carcinoma Metastases |
Drug: Avastin (bevacizumab) Drug: Tarceva (erlotinib HCl) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Multicenter, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Tarceva (Erlotinib Hydrochloride) in Combination With Avastin (Bevacizumab) Versus Avastin Alone for Treatment of Metastatic Renal Cell Carcinoma |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or anticipation of need for major surgical procedure during the course of the study
United States, California | |
Stanford University Medical Center | |
Stanford, California, United States, 94305 | |
UCLA School of Medicine | |
Los Angeles, California, United States, 90095 | |
Bay Area Cancer Research Group | |
Concord, California, United States, 94520 | |
Kaiser Permanente Medical Group | |
San Diego, California, United States, 92120 | |
United States, Colorado | |
UCHSC - Urologic Oncology | |
Aurora, Colorado, United States, 80010 | |
United States, Connecticut | |
Bennett Cancer Center | |
Stamford, Connecticut, United States, 06902 | |
United States, Florida | |
Lynn Regional Cancer Center - West | |
Boca Raton, Florida, United States, 33428 | |
United States, Louisiana | |
Ochsner Cancer Institute | |
New Orleans, Louisiana, United States, 70121 | |
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02215 | |
United States, Michigan | |
Wayne State University / Harper University Hospital | |
Detroit, Michigan, United States, 48201 | |
United States, Missouri | |
St. Joseph Oncology | |
St. Joseph, Missouri, United States, 64507 | |
United States, New Jersey | |
The Cancer Center at Hackensack University Medical Center | |
Hackensack, New Jersey, United States, 07601 | |
United States, New York | |
Our Lady of Mercy Medical Center | |
Bronx, New York, United States, 10466 | |
NYU School of Medicine | |
New York, New York, United States, 10016 | |
North Shore University Hospital | |
Manhasset, New York, United States, 11030 | |
United States, North Carolina | |
Northwestern Carolina Oncology & Hematology | |
Hickory, North Carolina, United States, 28601 | |
Raleigh Hematology Oncology | |
Raleigh, North Carolina, United States, 27609 | |
United States, Ohio | |
The Cleveland Clinic | |
Cleveland, Ohio, United States, 44195 | |
United States, Pennsylvania | |
University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19004 | |
Fox Chase Cancer Center | |
Philadelphia, Pennsylvania, United States, 19111 |
Study ID Numbers: | AVF2938g |
Study First Received: | April 15, 2004 |
Last Updated: | October 17, 2006 |
ClinicalTrials.gov Identifier: | NCT00081614 |
Health Authority: | United States: Food and Drug Administration |
Metastatic renal cell carcinoma |
Erlotinib Urogenital Neoplasms Bevacizumab Renal cancer Urologic Neoplasms Kidney cancer Carcinoma Urologic Diseases |
Kidney Neoplasms Neoplasm Metastasis Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Urinary tract neoplasm Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors Protein Kinase Inhibitors Angiogenesis Inhibitors |
Pharmacologic Actions Neoplasms Neoplastic Processes Neoplasms by Site Pathologic Processes Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors |